MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN BOSS-STM ADPTR XTRCTR; ADAPTORS

Model Number 2546-00-404

Device Problems Off-Label Use (1494); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon performing revision knee with attune revision system.Following reaming of tibial im canal and preparation of proximal tibia with sequential broaches the below broaches become stuck/wedged into the tibia and whilst surgeon attempted to extract the broach with the broach handles the couplings on the handles which attach to the broaches were disengaging with heavy mallet blows.Successfully extracted the broach using adaptor trial extractor (threaded into broach female recess).This was cross-threaded and now stuck in the size 45 tibial broach (surgeon aware this instrument not designed for broach extraction but remained the only option to attempt extraction of the tibial broach.Surgery completed successfully.No further information required.No further info available.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 clinical code: removed the code for insufficient information and replaced with no clinical signs, symptoms or conditions (e2403).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned instrument confirmed the reported event.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: ATUN BOSS-STM ADPTR XTRCTR
• Type of Device: ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10868239
• MDR Text Key: 217125696
• Report Number: 1818910-2020-24981
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295492023
• UDI-Public: 10603295492023
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2546-00-404
• Device Catalogue Number: 254600404
• Device Lot Number: GM5395703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/05/2020; 01/25/2021
• Supplement Dates FDA Received: 12/16/2020; 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1